FDA warns Bayer over Plant teting standards

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September 16, 2009

FDA warns Bayer over German manufacturing plant

U.S. health regulators have warned drug maker Bayer AG over quality

control issues at a plant that makes the key ingredient in popular birth

control

drugs. In a letter sent to Bayer, the Food and Drug Administration (FDA)

said it has concerns about how the company monitors and tests its drugs for

quality. A March 2009 inspection of the Bayer plant in Bergkamen, Germany

revealed problems with Bayer's system of quality control, the FDA said. The

drug ingredients included drospirenone, which is used in the popular birth

control pills Yaz and Yasmin. Those products were the company's top-selling

pharmaceuticals last year, with global sales of $1.8 billion. Recently

published studies found that pills which contain the hormones drospirenone or

desogestrel carry twice the risk of potentially fatal injuries than the

second generation medication first used in the 1970s. The Coalition against

Bayer Dangers demands a ban of " third generation " contraceptive pills with

increased rates of side effects.

The Bergkamen production facility makes ingredients for various

pharmaceutical chemicals used in steroid hormones. The FDA said that while

Bayer

promised to address the concerns raised after the inspection and vowed to

improve the quality control at the plant, corrective steps taken by the company

do " not adequately address some of the deficiencies. " The FDA said it will

consider delaying imports from the factory until Bayer addresses the

warning letter.

The FDA Warning Letter:

_http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm182206.htm_

(http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm182206.htm)

See also our Press Release: _“Remove dangerous contraceptive pills from

the market!â€_ (http://www.cbgnetwork.de/3068.html)

Coalition against BAYER Dangers (Germany)

_www.CBGnetwork.org_ (http://www.cbgnetwork.de/4.html)

CBGnetwork

Fax: (+49) 211-333 940 Tel: (+49) 211-333 911

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Advisory Board

Prof. Juergen Junginger, designer, Krefeld,

Prof. Dr. Juergen Rochlitz, chemist, former member of the Bundestag,

Burgwald

Wolfram Esche, attorney, Cologne

Dr. Sigrid Müller, pharmacologist, Bremen

Eva Bulling-Schroeter, member of the Bundestag, Berlin

Prof. Dr. Anton Schneider, biologist, Neubeuern

Dr. Janis Schmelzer, historian, Berlin

Dr. Erika Abczynski, pediatrician, Dormagen